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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pad, menstrual, unscented
510(k) Number K900421
Device Name PROMISE ABSORBENT PROTECTIVE PAD
Applicant
SCOTT HEALTH CARE
SCOTT PLAZA III
PHILADELPHIA,  PA  19113 -1585
Applicant Contact RICHARD A HAMER
Correspondent
SCOTT HEALTH CARE
SCOTT PLAZA III
PHILADELPHIA,  PA  19113 -1585
Correspondent Contact RICHARD A HAMER
Regulation Number884.5435
Classification Product Code
HHD  
Date Received01/30/1990
Decision Date 06/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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